Recall Z-1947-2018— Respire Medical

Name: FDA recall Z-1947-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-01

Class II · Terminated

Class II FDA medical device recall by Respire Medical, initiated 2017-09-01, terminated 2019-12-09. It names one FDA 510(k) clearance: K150572. Product: Respire Pink Series EF+ Oral Sleep Apnea Device.. Reason: Potential for device breakage during use.

Recalling firm: Respire Medical
Classification: Class II
Status: Terminated
Initiated: 2017-09-01
Terminated: 2019-12-09
Firm location: Brooklyn, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K150572 — Respire Pink Series-Herbst-EFRespire Medical Holding·cleared 2015-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Respire Pink Series EF+ Oral Sleep Apnea Device.

Reason for recall

Potential for device breakage during use

Data sourced from openFDA. This site is unofficial and independent of the FDA.